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A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System

NCT05156996 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2024-05-17

No results posted yet for this study

Summary

The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI.

Conditions

  • Anterior Acute Myocardial Infarction (AMI)

Interventions

DEVICE

Supersaturated O2 Therapy of the Therox Downstream System®

SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient's left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.

PROCEDURE

PCI alone

Percutaneous Coronary Intervention for treatment of acute MI

Sponsors & Collaborators

  • TherOx

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-04
Primary Completion
2024-01-04
Completion
2024-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156996 on ClinicalTrials.gov